FDA Drug Recalls

Recalls / Class II

Class IID-0235-2026

Product

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10

Brand name
Baclofen
Generic name
Baclofen
Active ingredient
Baclofen
Route
Oral
NDCs
51407-972, 51407-973, 51407-974
FDA application
ANDA215885
Affected lot / code info
Lot GS065762

Why it was recalled

Presence of Foreign Tablets/Capsules

Recalling firm

Firm
Golden State Medical Supply Inc.
Manufacturer
Golden State Medical Supply, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
5187 Camino Ruiz, Camarillo, California 93012-8601

Distribution

Quantity
2472 HDPE Bottles
Distribution pattern
Nationwide within the USA

Timeline

Recall initiated
2025-11-26
FDA classified
2025-12-15
Posted by FDA
2025-12-24
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0235-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: Baclofen · FDA Drug Recalls